510(k) K051124 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ZILVER 635 BILIARY STENT
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Unknown, Jul 12, 2005 |
| Received | May 3, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2006 | Cook, Inc. Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wi Terminated |
FGE | None listed |
| Mar 9, 2006 | Cook, Inc. Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wi Terminated |
FGE | None listed |
| Jan 13, 2006 | Cook, Inc. Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommen Terminated |
FGE | None listed |
| Jan 13, 2006 | Cook, Inc. Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommen Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.